Restoring Sinus Rhythm Using Dual-Shock Technique in Patients With Atrial Fibrillation

Официальное название

Restoring Sinus Rhythm Using DUAL-electrical SHOCK Technique: the DUAL-SHOCK Trial

Обзор

The goal of this clinical trial is to assess the efficacy and acute safety of the dual electrical cardioversion (ECV) technique compared with the conventional ECV in patients with persistent atrial fibrillation. The main question it aims to answer are: * Is dual ECV more effective than conventional ECV to achieve sinus rhythm restoration? * Is dual ECV safe compared with conventional ECV? * Which are the main factors associated with cardioversion success? Researchers will compare a dual ECV technique with 400J with dual ECV with 200J and conventional ECV. Participants will be randomized to one ECV configuration. The primary efficacy endpoint will be considered the percentage of patients with successful cardioversion with the first shock. The coprimary safety endpoint will be the occurrence of adverse events during ECV.

Вмешательства

• Процедура Conventional Electrical Cardioversion
  Defibrillation pads will be placed in the anteroposterior or anterolateral position. An initial biphasic shock of 200 J will be delivered. If sinus rhythm is not restored, a second dual shock of 400 J (crossover) will be administered. The procedures will be performed in the designated area for such procedures at each center, under deep sedation in accordance with each center's standard protocols. The choice of medication used for sedation will be at the investigator's discretion. All shocks wil
• Процедура Dual-shock Electrical Cardioversion
  Two pairs of defibrillation pads connected to two different defibrillators will be used. One pair of pads will be placed in the anterolateral position and the second pair in the anteroposterior position. Both defibrillators will be programmed to deliver a biphasic shock of 100 J each (200 J group) or 200 J each (400 J group) simultaneously. The maximum number of CVE attempts per patient will be 3. The procedures will be performed in the designated area for such procedures at each center, under

Первичные конечные точки

• Primary Efficacy Outcome - Patients achieving sinus rhythm with the first shock [Срок оценки: First minute after first shock delivery]
• Primary Safety Outcome - Adverse events during the procedure [Срок оценки: Before patient are discharged]

Вторичные конечные точки (4)

• Overall Procedural Sucess [Срок оценки: The end of the procedure]
• Overall Intervention-Specific Success [Срок оценки: First minute after shock delivery]
• Total Energy Delivered [Срок оценки: End of the procedure]
• Sub-acute procedural success [Срок оценки: At 30 (25-35) days after the procedure]

Критерии участия

Критерии включения

• Diagnosis of persistent AF.
• Effective anticoagulation for at least 3 weeks prior to the procedure or exclusion of intra-atrial thrombus by transesophageal echocardiography within the last 24 hours.
• Informed consent obtained.

Критерии исключения

• Long-standing persistent atrial fibrillation (more than 1 year of uninterrupted AF rhythm).
• Emergency indication (hemodynamic instability).
• Cardiac defibrillation following catheter ablation procedures. Cardiac defibrillation performed during the same procedure will be permitted if it is carried out prior to ablation.
• Pregnancy.
• Age <18 years or legal incapacity.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07560644 · 25-129

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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